DUNS NUMBER

A DUN’S number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B), a business credit bureau. The DUNS Number is location specific. So, each physical location of an entity such as branches, divisions, and headquarters may be assigned a DUN’S number separately.

To market food, drugs and medical devices products in the United States, companies must have DUNS number.

Food: All domestic and foreign food facilities what wants to sell their food products in the US will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. DUNS number is the only acceptable UFI recognized by FDA.

For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.

For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

Drugs: US FDA will directly pull the company information only from FDA’s DUNS portal. So, companies who want to register with FDA must obtain DUNS first and then proceed with registration.

Medical Devices: Even though for now, DUNS number is not mandatory to register, to submit Unique Device Identification (UDI), DUNS is a mandatory requirement.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUN’S number first. DUNS requests may take up to 30 days.

Liberty Management Group, as leading FDA consultant provide assistance with DUNS number lookup and FDA registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

SELF-IDENTIFICATION

The FDA Self-Identification applies to facilities and organizations involved in the development and manufacturing of generic drugs.

Facilities that manufacture or intend to manufacture must submit Self-Identification.

  • Active Pharmaceutical Ingredients (API) of human generic drugs.
  • Finished Dosage Forms (FDF) of human generic drugs.
  • Sites and organizations involved in:
  • Bioequivalence (BE)/bioavailability (BA) sites that are registered as a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing)
  • Testing, repackaging, or relabeling of generic drugs (exempt from user fees)

Self-Identification must be submitted via CDER Direct or ESG portal by generating SPL files.

Under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded.  It is a violation of federal law to ship misbranded products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products are considered as misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States.

Self-identification must be submitted between May 1 and June 1 of each year.

Liberty Management Group LTD, as a leading FDA consulting firm provides assistance with SPL preparation and submission of Self-Identification to FDA.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

STEPS INVOLVED IN MEDICAL DEVICE REGISTRATION

The FDA medical device registration process involves multiple steps to ensure the device meets safety and regulatory standards.

Registration Requirements:  The FDA classifies devices into various risk categories Class I, II, III based on their complexity and potential risks.  Based on their classification, the registration requirements vary.  For critical devices, first they must get 510K clearance or PMA and then register.

Pay the Registration Fee:  The FDA requires an annual registration fee for device establishments. Companies can make the payment by creating a user fee account with FDA and obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN).

Obtain a FURLS Account:  The FDA uses the Facility and Registration Listing System (FURLS) for device establishment registration and product listing. Companies must create a FURLS account to complete the registration process.

Register the Facility:  Register the establishment that manufactures or distributes the medical device with the FDA through FURLS. This involves providing details like owner information, facility location, and the type of activities your establishment performs related to the device.

Device listing:  Once the facility is registered, list the specific medical device in FURLS. Devices can be identified with the product codes which indicate if the device needs premarket notification or 510k number. If product code needs 510K clearance or PMA, then the device must be listed with appropriate 510K or PMA numbers.

All medical device establishments must renew their registration between October 1st and December 31st every year if they want to market the device in the next FY.

Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

LABEL COMPLIANCE

FDA labeling compliance requirements vary for each product. In general, information on the label must be truthful and not misleading, labels should include all the required information for the product category, wording and formatting should be easy for consumers to understand.

Below are basic requirements for each product category.

Food

  • Ingredient list
  • Nutrition information panel
  • Allergen warnings
  • Name and address of the manufacturer.
  • Net quantity of contents

Medical Devices

  • Intended use of the device
  • Directions for use
  • Warnings and precautions
  • Sterilization information (if applicable)
  • Manufacturer information

Drugs

  • Drug facts table.
  • Intended use of the drug with active ingredients concentration.
  • Warnings and precautions.
  • Directions of use
  • Inactive ingredients
  • Manufacturer information
  • Expiration date

Cosmetics

  • Principal Display Panel (PDP)
  • Product Name
  • Identity Statement
  • Net quantity and Ingredient list
  • Warning and Precautions

The FDA provides comprehensive guidance documents to help navigate the complexities of labeling compliance.

The FDA does not pre-approve labels, so manufacturers are responsible for ensuring compliance.

Liberty management Group, LTD as a leading FDA consulting firm provides assistance with Food, Drug, Medical devices and Cosmetics labeling compliance.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

DRUG LISTING

All domestic or foreign establishments that manufactures or commercially distributes human drug and animal products within the U.S., you are subject to drug establishment registration and drug listing requirements. Establishment Registration and drug listings lets FDA to develop and maintain a catalog of all drug products marketed in the U.S. Registration information provides the locations and contact information for drug establishments and determines sites for inspection. Drug product listing information provides an inventory of all drug products in the market with manufacturing information, which includes inactive ingredients incorporated into marketed drug products. The FDA depends on this registration and listing information for controlling key programs, including post-marketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application. The electronic drug establishment registration and drug listing system (eDRLS) also populates electronic listing databases such as DailyMed and the National Drug Code (NDC) Directory, improving the accuracy and inclusiveness of these databases.

Drug establishments (manufacturers/contract manufacturers, re-packagers, re-labelers) – domestic and foreign – must register with the US FDA and list their products.

There is no registration requirement for Private Label distributors, but they must list their products under their own NDC number.

Listing can be done electronically via ESG portal or FDA’s CDER direct.

Listings must be updated every June and December, or sooner if there are any changes. There is also an annual renewal period (October 1 to December 31) for certification which is called No-change certification (Blanket listing submission)

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

U.S AGENT

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a food, drug, medical device, and cosmetics imported into the United States must identify a U.S. agent for that establishment.

Information about a foreign establishment’s U.S. Agent must be electronically using the FDA FURLS system or CDER/ESG and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone, and e-mail address of the U.S. agent.

Responsibilities of a U.S. agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S and they cannot use P.O. BOX as the address. U.S agents must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

  • Assisting FDA in communications with the foreign establishment, meaning that function as a mediator between the client and the FDA.
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States,
  • Assisting FDA in scheduling inspections of the foreign establishment and
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Liberty Management Group, a leading FDA consulting firm provides assistance with US agent services all foreign food, drug, medical devices and cosmetics establishments.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER WITH FDA?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, medical devices, food (including animal food), cosmetics, and tobacco products. It also regulates electronic products that emit radiation.

Foods:

The FDA regulates the safety, labeling, and quality of all other food products except for meat, poultry, and egg products, which are regulated by the US Department of Agriculture (USDA).

In general, it includes Fresh and processed foods, Dietary supplements, Bottled water, Food additives, Infant formulas, fruits, and vegetables.

Drugs:

The FDA regulates the safety, effectiveness, and quality of all human and animal drugs, which includes prescription and over-the-counter drugs, homeopathic drugs, active pharmaceutical ingredients and vaccines and other biological products.

Medical Devices:

The FDA regulates the safety, effectiveness, and quality of all medical devices used in humans which includes a wide range of devices, from simple bandages to complex surgical implants.

Cosmetics:

The FDA regulates the safety of all cosmetics, including makeup, skincare products, and hair care products, Hair care products, lotions, and moisturizers.

Products are categorized based on the label claims and regulated according to intended use.

Liberty Management Group Ltd, as a leading FDA consulting firm providing assistance with FDA registration of food, drug, medical devices and cosmetic products.

Liberty Management Group Ltd, as a leading FDA consulting firm will provide assistance with above all regulatory requirements.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

DRUG REPORTING FINAL GUIDANCE

FDA has issued a new guidance on drug reporting under which registrants of drug establishments are required to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of FD&C act.

As per the guidance, the registrants are required to submit a list of all drugs they manufacture, prepare, propagate, compound, or process for commercial distribution annually. This list must include the name and National Drug Code (NDC) of each drug, as well as other information such as the dosage form, strength, route of administration, and package size.

In the guidance FDA refers “Registrant” as any person that owns or operates an establishment that manufactures, repacks, relabels, or salvages a drug, and is not otherwise exempt from establishment registration requirements under section 510 of the FD&C Act or 21 CFR part 207. See § 207.1.

FDA requires all registrant of drug establishment which includes prescription drugs, over the counter (OTC) drugs, and biologic products, re-packers and re-labelers, active pharmaceutical ingredient (API), and other types of listed drugs, medical gases, homeopathic products, animal drug products, and distributors to submit drug reporting to the agency.

For private label distributors, the data should be submitted separately by the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.

Reports on the amount of each registrant’s listed drugs must be submitted yearly. Such reports should include information regarding the amount of drug released for the respective calendar year (January 1 – December 31) and should be submitted no later than March 31st of the following fiscal year.

Liberty Management Group, as a leading FDA consulting firm, can help you in submitting the drug reports to FDA on time.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG) – NE (Certificates to Foreign Government for Device Not Exported from the United States.)

Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) is document issued by FDA issued for legally marketed devices in the U.S that are manufactured by the companies located outside of the United States and are in compliance with the regulations of FD&C act.

Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is not being exported from the U.S.

Requirements to get the Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE)

  1. The manufacturing facility must have a valid medical device establishment registration and must be located outside of the United States.
  2. All devices must be listed with the FDA.
  3. The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
  4. The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
  5. The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
  6. Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action.
  7. Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified

Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers to request export documents online. CECATS can be accessed by logging into the FDA Furls account.

The fees for export certificate from CDRH are $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

REGISTRATION DE-ACTIVATION

The consequences of not renewing US FDA registration can be significant, depending on the type of facility that operates and the products they manufacture.

Food facilities:

Expired registration: If your registration expires, the FDA will consider it a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Seizure of products: The FDA may seize the products if they believe that the products are manufactured in an unregistered facility or pose a public health risk.

Injunctions: The FDA may seek a court order to prevent from continuing to operate your facility until you come into compliance.

Loss of business: Potential customers and suppliers may be hesitant to do business with a facility that is not in good standing with the FDA.

Medical device establishments:

Expired registration: Like food facilities, an expired registration for a medical device establishment is a violation of the FD&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for medical devices manufactured in unregistered establishments.

Import restrictions: The FDA may restrict the import of medical devices manufactured in unregistered establishments.

Drugs

Expired registration: Like other registration, an expired registration for drug establishments is also violation of FDA&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for drugs manufactured in unregistered establishments. They will consider the drug as misbranded and de-activate all the drugs listed FDA.

Import restrictions: The FDA may restrict the import of drugs manufactured in unregistered establishments. Also, they may seize the products if they believe they are manufactured in an unregistered facility or pose a public health risk.

Liberty Management Group, as a renowned FDA consulting firm can help the companies in renewing the food establishment, drug establishment and medical device establishments in a timely manner.

Sudha

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us